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JM-103
Dräger JM-103 User Manual
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W
ARNING
T
o properly
use this medical
device, the user
must obt
ain a
full understanding of the per-
formance characte
ristics of
this medical device prior to
use by carefully reading the
se
Instructions for Use.
Model JM-103
Instructions for Use
Dräger Jaundice Meter
2
Table of Contents
Default Chapter
3
Table of Contents
3
Section 1: Symbol Definition and Intended Use
5
Symbol Definition
5
Intended Use
8
Section 2: Introduction, Features, and Specifications
11
Introduction
11
Measuring Point
11
Explanation of the Test
12
Features
16
Controls, Indicators, and Connections
16
Display
18
Standard Features
19
Specifications
20
Standard Features
20
Regulations, Standards, and Codes
21
Device Classification
21
Electromagnetic Compatibility (EMC) Guidance and Manufacturer's Declarations
22
Section 3: Precautions and Safety Tips
27
Precautions
27
Electromagnetic Compatibility Precautions
29
Safety Tips
30
Warning and Caution Labels
31
Section 4: Installation and Assembly
33
Installation
33
Charging the Battery
33
Selecting the Unit of Measurement
35
Operational Checkout of the Jaundice Meter
36
Section 5: Instructions for Use
39
Instructions for Use
39
Taking Measurements
39
Setting the Number of Average Measurements
43
Taking Average Measurements
44
Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling
47
Cleaning
47
Steam Cleaning
47
Cleaning Difficult to Access Areas
47
Disinfecting
48
Maintenance
48
Calibration
48
Replacement Parts
49
Storage and Handling
50
Disposal
51
Section 7: Troubleshooting
53
Service Calls
53
Error Messages
53
Troubleshooting
54
Appendix A: Clinical Performance Summary
57
Introduction
57
Study Design
57
Performance Data
59
Conclusion
73
Appendix B Doctors' Office Data
75
Study Design
75
Performance Data
77
Conclusion
82
Appendix C: Medical and Scientific References on Transcutaneous Bilirubinometry
83
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Dräger JM-103 Specifications
General
Brand
Dräger
Model
JM-103
Category
Measuring Instruments
Language
English
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